Coala Life Coala User manual

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USER MANUAL COALA HEART MONITOR

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“Made for iPhone” mean that an electronic accessory has been designed
to connect specifically to iPhone and has been certified by the developer
to meet Apple performance standards. Apple is not responsible for the
operation of this device or its compliance with safety and regulatory
standards. Please note that the use of this accessory with iPhone
may affect wireless performance. iPhone is a trademark of Apple Inc.,
registered in the U.S. and other countries.

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Table of contents
1. Product Description ................................................ 4
2. Indications for Use .................................................. 8
3. Contraindications.................................................... 8
4. Cautions.................................................................. 9
5. Warnings............................................................... 12
6. Storage ................................................................. 15
7. Cleaning and Maintenance.................................... 16
8. Using the Coala ..................................................... 16
9. Coala LED indications............................................ 50
10. ECG Categorization ............................................... 51
11. Troubleshooting .................................................... 56
12. Electrical safety .................................................... 63
13. Transceiver properties........................................... 64
14. Electrical emission................................................ 64
15. Electrical immunity............................................... 65
16.
Warning related to electromagnetic compatibility ... 67
17. Symbols used on system and package label.......... 68
18. Specifications ....................................................... 71
19. Contact information to the Manufacturer.............. 75

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Introduction
Congratulations on your new Coala! Please read this manual
for important safety information and to get the most out of the
Coala Heart Monitor.
1. Product Description
The Coala Heart Monitor is a patented medical device. It
records clinical quality ECG (electrocardiogram) and heart
sounds simultaneously. The device can be used by both
healthcare professionals and health conscious individuals.
Both ECG and heart sounds recordings are available for your
Healthcare professional.
The Coala Heart Monitor consists of the following parts:
• A small hand-held device that is pressed against the chest
for simultaneous recordings of ECG and heart sounds
through electrodes and a stethoscope membrane followed
by a thumb ECG measurement.

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• The Coala app that is installed on a smartphone and is used
to perform measurement together with Coala, collect and
view recordings.The Coala app transmitts recordings to the
Coala Care Portal and receives analyzed results from the
same server. It also features a messaging system where you
can receive notifications from your Healthcare professional.
• A user-supplied compatible smartphone running iOS or
Android, listed on the Coala Life website:
www.coalalife.com/device-compatibility
• Coala Care Portal is the server that provides automatic
detection of the cardiac rhythm deviations, stores all your
recordings and handles your Coala account.
• The
Coala Charge Station that is used to charge the battery
in the Coala.The Coala can be charged from the supplied
wall adapter or any compatible USB outlet. Ensure the
battery is charged regularly, and that it is fully charged
before first use.
• The Coala cover and the travel bag to is provided to protect
the Coala device during transportation and storage.

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The Coala Heart Monitor is intended to be used by a single
individual to:
• Record simultaneous ECG and heart sounds.
• Recieve results from detection of cardiac rhythm deviation.
• Annotate each recording with symptoms or free text.
• Access recordings from the Coala Care Portal and download
pdf file recordings.
• Receive messages from your physician. (If connected
through the Coala Care Portal)
Chest and thumb ECG recordings
The Coala can measure ECG on the chest and on the thumbs.
The measurement on the chest is done by holding the Coala
to the chest and the thumb measurement by gently pressing
both thumbs on the electrode on the bottom of the Coala.
Since the recorded signal depends on the location on the chest,
a finger ECG is also always obtained for reference.

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Simultaneous ECG and heart sound recordings
The mechanical movement of the valves in the heart creates
heart sounds that can be used for assessing the mechanical
condition of the heart. These sounds can be recorded by the
Coala and can be used by a trained medical professional for an
assessment of the heart (when prescribed or used under the
care of a Healthcare professional). The unique Coala feature is
the ability to record simultaneous ECG and heart sounds. This
combined information can be used by a trained cardiologist to
give a detailed view of the electrical and mechanical activity
of your heart.

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2. Indications for Use
The Coala Heart Monitor is intended for self-testing by
patients to record, store, transfer and display surface ECG and
sound to aid the detection of heart and respiratory conditions.
The Coala Heart Monitor is intended for use by healthcare
professionals, individuals with known or suspected heart
conditions and health conscious individuals.
The Coala Heart Monitor is not intended for use for vital
monitoring as in intensive care.
3. Contraindications
There are no known contraindications for Coala Heart Monitor.

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4. Cautions
• Do not use this device in a wet environment. Do not use a
device that has been submerged in water. The Coala device
carries an Ingress Protection (IP) rating of IP22 meaning that
vertically dripping water has no harmful effect when the
enclosure is tilted at an angle up to 15° from its normal (laying
down flat with stethoscope membrane facing down). Note that
the Charge Station, wall adapter and USB cable do not carry
an IP rating and are only to be used in a dry environment.
• Do not use this device in dusty environments such as
machine shops. Use the protective cover and bag to keep
the device clean. Note that the IP22 rating of the Coala
device does not mean that it is dustproof.
• Do not use this device in locations subject to extreme high
or low temperatures or humidity for this reason do not leave
the device in vehicle.
• Do not use a device that shows signs of mechanical damage
or loose parts.
• Do not sterilize this device with an autoclave, gas sterilizer
or using radiation such as gamma or E-beam sterilization.
• Do not take recordings in the presence of strong
electromagnetic fields such as near an arc welder,

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high power radio transmitter etc as these can cause
disturbances to recorded signals. Note that recordings
performed in vehicles (cars, buses, trains, aircraft etc) may
see disturbances due to electromagnetic interference as
from motors and ignition systems.
• Do not expose the device to strong shocks or vibrations.
• Recordings may be interrupted by strong electromagnetic
interference, shocks and vibrations.
• Always protect the membrane from sharp objects such as
keys, pencils etc.
• Do not disassemble, repair or modify the device in any way.
• This device is not intended to be operated by children,
elderly or persons with physical or mental impairment. Let
an able accompanying adult operate the device.
• Do not take recordings if the ECG electrodes are dirty. Clean
them first.
• Do not use for any purpose other than to obtain ECG and
sound recordings.
• The Coala Heart Monitor has not been tested for use on
infants less than 12 months old. Due to chest size and
electrode placement Coala Life does not recommend using
on humans weighing less than 10 kg.

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• A successful chest recording may not be possible if the
device is applied to a chest which has too much body hair,
body fat or very dry skin. Try to apply moisture to the skin and
shave off any body hair to obtain successful recordings.
• The Coala should be applied only to intact, clean skin (e.g., not
over open wounds, lesions, infected, or inflamed areas).
• Not to be used with a pacemaker. If the Coala is used with a
pacemaker, pacing pulses may be detected and counted by the
heart rate display but may not be displayed in the ECG graphs.
• ECG-filters may distort baseline properties and high-
frequency response of the ECG signal. The full signal without
filters is available for healthcare professionals in the Coala
Care Portal. Signal amplitudes for the chest ECG measurement
are typically lower (0.1 to 0.4 mV) than on conventional chest
leads due to close electrode spacing on the Coala. Chest signal
morphology is also affected by positioning of the Coala on the
chest and may not resemble conventional chest leads.
• Not suitable for direct cardiac application (intact skin only).
• To avoid intrusion and leakage of personal data to
unauthorized persons lock the phone or logout from Coala
App between measurements.

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• Contact Coala Life of any signs of malicious system
behaviour, suspicions of malware or system cybersecurity
violations.
• Coala Life does not recommend using on individuals with
a cardiac pacemaker, ICDs or other implanted electronic
devices.
• Maximum T-wave amplitude is 1.5 times the QRS amplitude
for correct display of heart rate.
5. Warnings
• This device is not intended for complete diagnosis of
cardiac conditions.This device should never be used
as a basis for starting or modifying treatment without
independent confirmation by medical examination.
• This device does not detect or measure all heart rate, heart
rhythm and heart waveform changes, especially those related
to ischemic heart conditions. Always consult your Health Care
Professional if you experience changes in your health.
• Do not attempt self-diagnosis or self-treatment based
on the recording results and analysis. Always consult a
medical professional.

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• Interpretations made by this device are potential
findings, not a complete diagnosis of cardiac conditions.
All interpretations should be reviewed by a medical
professional.
• Keep out of reach of infants, small children and animals to
avoid strangulation by the supplied USB cable.
• This device is not intended to be operated by children,
elderly or persons with physical or mental impairment. Let
an able accompanying adult operate the device.
• Not for pediatric use.
• It is not recommended to place a mobile phone directly
next to a pacemaker or ICD (Implantable Cardioverter
Defibrillator) as this may disturb your implantable device.
• Do not use the Coala with a defibrillator. The Coala is not
defibrillator proof and may be damaged or reduce the
effectiveness of the defibrillation.
• Do not use device in explosive environments (mines, oil
rigs, fueling stations, oxygen rich environments such as
hyperbaric chambers or in the presence of flammable
anesthetics).

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• Do not connect the Coala Charge Station to any power source
or external equipment other than described in this manual.
• Do not dispose in fire. Contains lithium battery that may
explode. Dispose as electronic waste according to local
regulations.
• The heart rate is based on the heart rhythm; therefore the
rate is only valid if there is a valid detected rhythm.
• Warning: MR-unsafe! Do not expose the device to a
magnetic resonance (MR) environment. The device may
present a risk of projectile injury due to the presence of
ferromagnetic materials that can be attracted by the MR
magnet core.Thermal injury and burns may occur due to
the metal components of the device that can heat during
MR scanning. The device may generate artifacts in the MR
image. The device may not function properly due to the
strong magnetic and radiofrequency fields generated by the
MR scanner.
• Not for use with High Frequency Surgical Equipment.

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6. Storage
Store the Coala indoors in the supplied travel bag with
the cover to protect the membrane and the electrodes.
Temperature +5 °C to +35 °C / 41 to 95 °F. Humidity 15 % to
90 %, non-condensing. Air Pressure 700 to 1060 hPa /10,2 to
15,4 psi.
Do not store the device in:
• Locations exposed to direct sunlight.
• Locations subject to high temperatures such as in vehicles
high and low temperatures and high humidity.
• Wet or damp locations where the device may be in contact
with water.
• Dusty locations.
• Near fires or open flames.
• Locations exposed to strong vibration.
• Locations exposed to strong electromagnetic fields.
• Locations exposed to chemicals or solvents of any kind.

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7. Cleaning and Maintenance
Use only a wet cloth or alcohol to clean the Coala and accessories.
Do not use other solvents like acetonce och petroleum based
chemicals. There are no parts that need regular service or
maintenance. Cleaning and maintenance: For Multi use Coala
please clean the Coala between different users with 70% Alcohol.
8. Using the Coala
8.1. Check Smartphone Compatibility
The Coala Heart Monitor is compatible with smartphones
running iOS (iPhone 5 or later) or Android (4.4 KitKat) listed on
the Coala Life website:
https://www.coalalife.com/device-compatibility
8.2. Unpack and Charge the Coala
Unpack the Coala Charge Station from the box and place it
flat on a table. Unpack the wall adapter and connect the USB
cable between the Coala Charge Station (small USB plug) and
the wall adapter (large USB plug). Charge the Coala by sliding
it carefully into the Coala Charge Station as shown. You are
now ready to charge the Coala and bring it to life!

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Make sure the Coala is charged regularly and is fully charged
before the first use.
Connect the wall adapter to a mains power outlet. The Coala
should now start blinking with a blue light to indicate that it is
charging. If not, repeat the steps above and make sure that the
Coala has been correctly placed in the Coala Charge Station.
The Coala will show a steady blue light once it is fully charged
(up to about 2 hours charging time).
The Coala can also be charged from a laptop, battery pack
or other source such as a power supply/wall adapter with a
USB port that can support 300 mA of current. Simply plug the
USB cable between the Coala Charge Station and the source
instead of using the supplied wall adapter.

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NOTE!
The Coala should be carefully placed in the Coala Charge Station by noting
correct orientation and sliding it into place. Do not use force or press straight
down on the Coala to get it in place. For maximum electrical safety the Coala
cannot be used for obtaining recordings while charging since the Coala Charge
Station and connected wall adapter are IT type equipment and do not carry the
type BF (Body Floating) medical electrical safety rating that the Coala does.
NOTE!
If an external power supply/wall adapter is used it must be a class II
power supply (no connection to protective earth) with an output voltage
of 5VDC and capable of at least 300 mA of current.
To remove the Coala from the Coala Charge Station, push
against it using your thumb. Do not try to lift it directly out of
the Coala Charge Station!

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8.3. Download the Coala App
Start by downloading the Coala App from the Apple App Store or
Google Play depending on your smartphone. Search for ”Coala App”.
Follow the instructions for your phone to install the Coala App.
8.4. Coala Account Setup
Enter the username and password you chose when you signed
up for the service. Follow the intuitive instructions in the
app to set up your personal Coala account. If you wish to be
included in the Coala Atlas, enter your personal details.
1. Coala Atlas allow your recodings to be used for research.
Read text and select to participate or not. To participate
anonymously click on the link in the message. This can also
be selected later in the app.
2. Health data: Gender, length, weight, medication (add if yes),
smoking habits, pacemaker or other implatable device.

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8.5. Pair the Coala to your phone
Use these steps to connect your Coala to the Coala App on
your phone.
1. Make sure that your bluetooth is not connected to another
device when you make recordings with the Coala Heart
Monitor.
2. Make sure that bluetooth is enabled on your phone. It is
found in the Settings tab on your phone.
3. Power on the Coala by briefly pressing the Power button
. Your Coala should now be blinking green in rapid
succession.
4. Press the “Connect Coala” button in Coala App and follow
the instructions.
5. Press “My Coala is powered on” and the press “Show the
list of devices” and select the serial number of your Coala
in the list.
8.6. Tips and tricks
Sit down comfortably during recording for best results. Avoid
lying down or standing up. For correct placement of the Coala